Kornimate/medical-research-clean huggingface dataset:
daily protein intake patterns on energy metabolism and the motivation to snack

Conditions: Obesity

Summary: the purpose of this study is to determine if when one eats protein can change how the body uses food for energy. researchers will also test if eating a high protein breakfast can change one's craving for snack foods.

the purpose of this study is to determine if consuming 30 g of high-quality protein at each meal can increase fat utilization and shift between-meal snack choices. while the benefits of high-protein diets are well known, little is known about the optimal amount of protein that should be eaten at each meal. most americans eat little protein at breakfast and lunch and most of their protein at the evening meal. current guidelines for protein are based on body weight; however, recent evidence indicates that absolute amounts of protein at each meal are needed to maintain metabolically active fat-free mass. this suggests that a more even protein consumption pattern across daily meals may positively influence energy metabolism. in addition, recent evidence indicates that protein may reduce activity in the food reward areas of the brain. this suggests that protein may influence between-meal snacking by decreasing the relative reinforcing value (rrv) of highly rewarding snack foods. the rrv of a food is an empirical measure of its motivating value and energy-dense foods are highly reinforcing, especially for obese individuals. this study will be the first to investigate the role of the daily distribution of protein intake on energy metabolism and modifying snacking behavior.

Eligibility criteria:
inclusion criteria: * bmi \< 25 kg/m2 * bmi ≥ 30 kg/m2 but \< 34.5 kg/m2 * able to understand and sign the informed consent * able to provide own transportation to the center * free of any major illness/disease * usual protein intake within the acceptable macronutrient distribution range (10 to 30%) * constant habitual activity patterns within the last 3 months * females of childbearing age must be on birth control for a minimum of 3 months prior to study start and have regular menstrual cycles exclusion criteria: * unable or unwilling to consume animal products * have had more than a 10% change in body weight within the past 2 months * are participating in a weight loss diet/exercise program * are consuming a specialized diet * currently or planning on becoming pregnant during the study timeline * lactating * have a metabolic illness/disease * have uncontrolled hypertension * have ever had cancer * have an infectious disease * suffer from alcohol or drug abuse * use tobacco and e-cigarette products on a regular basis * have the presence of acute illness * taking medications known to affect energy expenditure and appetite
spinal aesthesia in women with placenta previa percreta

Conditions: Complications; Cesarean Section

Summary: placenta previa percreta is a dangerous complication during surgery. due to the high risk of hemorrhage, most parturients with placenta previa have to accept cesarean section. in this study investigators compare the effect of different anesthetic techniques on these patients.


Eligibility criteria:
inclusion criteria: * women with placenta previa and increta-percreta (diagnosed by ultrasound and/or magnetic resonance imaging and confirmed during cesarean section) * women accepted cesarean section exclusion criteria: * women with baseline systemic blood pressure higher than 180 mmhg * women with coagulation disorder

Keywords: cesarean section spinal anesthesia general anesthesia
cognitive remediation and functional skills training in schizophrenia

Conditions: Schizophrenia; Schizoaffective Disorder

Summary: this randomized trial is examining whether a treatment called cognitive remediation is more effective when it is paired with a social and functional skills training component.


Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia or schizoaffective disorder * enrolled in outpatient mental health care * reading level of 6th grade or higher * english speaking exclusion criteria: * medical conditions known to affect cognition

Keywords: schizophrenia psychosis schizoaffective disorder
screening for hemoglobinopathies in pregnant women

Conditions: Hemoglobinopathies

Summary: this prospective monocentric study project is to identify hemoglobinopathies in pregnant women in order to optimize antenatal care and to investigate the prevalence of hemoglobinopathies in pregnant women in switzerland.


Eligibility criteria:
inclusion criteria: * pregnant women seen at the frauenklinik at university hospital basel exclusion criteria: * pregnant women with already known hemoglobinopathy * refusal of participation

Keywords: thalassemia sickle cell anaemia molecular genetic analysis
inspire home study: utilization of home monitoring during therapy optimization in patients with an inspire upper airway stimulation system (comparison of home sleep testing vs. in-lab polysomnography testing)

Conditions: Obstructive Sleep Apnea

Summary: inspire intends to conduct this study to compare apnea-hypopnea index (ahi), between the two randomization arms, at 6 months post-activation

this study is a prospective, randomized, non-blinded, multi-center study of therapy optimization related to the inspire uas system (implanted in a commercial setting under current labeling). comparison of outcomes between two (2) groups of patients (both implanted with the inspire uas system) who undergo different post-implant care algorithms throughout follow-up, in order to determine whether home sleep monitoring may be used as a surrogate for an in-lab psg titration in a sub-set of patients. subjects who have been identified as candidates for inspire therapy (implant of the inspire uas system), according to commercial labeling, will be recruited to participate in the study. a maximum of 100 subjects will be enrolled at up to 5 clinical centers. a total of 60 subjects will be randomized (1:1) to one of two study arms.

Eligibility criteria:
inclusion criteria: 1. patient is ≥ 22 years of age; 2. patient has been diagnosed with moderate to severe osa, with a baseline (pre-implant) ahi ≥ 15 based on a qualified sleep study; 3. patient has been implanted with the inspire uas system but not yet activated, or has been scheduled for implant of the inspire uas system; 4. patient currently owns a smartphone and is willing and able to install and use smartphone apps (at no cost to patient); 5. patient is willing to utilize study equipment at home including home sleep test (hst) equipment, pulse oximetry equipment, and sleep tracking equipment in accordance with the study protocol; 6. patient is willing and able to return for all follow-up study visits; 7. patient is willing to be randomized and adhere to randomization allocation; 8. patient is willing to and capable of providing informed consent. exclusion criteria: 1. patient has central + mixed apneas more than \> 25% of the total ahi; 2. patient currently uses adjunctive sleep therapy (eg. cpap, oral appliance, positional therapy) and will not discontinue use of adjunctive therapy upon implant of the inspire uas system; 3. patient is pregnant or plans to become pregnant; 4. patient has a terminal illness with life expectancy \< 12 months; 5. any other reason the investigator deems that the patient is unfit for participation in the study.

Keywords: osa
pharmacokinetic/pharmacodynamic study of udenafil in adolescents

Conditions: Single Ventricle Heart Disease After Fontan Surgery

Summary: to determine the pharmacokinetic profile and safety of udenafil in adolescents with fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular performance, and vascular function.

a dose escalation trial to determine the pharmacokinetics, safety and tolerance of udenafil in male and female adolescent subjects with single ventricle physiology that that have undergone the fontan surgical procedure. pharmacodynamic data will also be collected to evaluate the effect of udenafil on acute exercise performance, peripheral vascular function and indices of myocardial performance. five udenafil cohorts will be evaluated in additional to one drug free cohort

Eligibility criteria:
inclusion criteria: 1. males and females with fontan physiology who are 14-18 years of age. 2. willingness to return to center to complete blood draws and exercise tests as described in the study protocol. 3. patients must agree to abstain from alcohol, caffeinated beverages, and grapefruit juice for the duration of the trial. 4. informed assent from subject informed consent from parent/legal guardian as appropriate. exclusion criteria: 1. non-cardiac medical, psychiatric, and/or social disorder that would prevent successful completion of planned study testing or would invalidate its results. 2. height \<132 cm (minimum height requirement for exercise stress testing). 3. known fontan baffle obstruction, branch pulmonary artery stenosis, or pulmonary vein stenosis resulting in a mean gradient of \>4 mmhg between the regions proximal and distal to the obstruction. 4. single lung physiology. 5. severe ventricular dysfunction or valvular regurgitation (systemic atrioventricular or semilunar valve) determined from review of the echocardiogram performed in closest proximity to study enrollment. 6. significant renal (serum creatinine \> 2.0), hepatic (serum aspartate aminotransferase (ast) and/or alanine aminotransferase ( alt) \> 3 times upper limit of normal), gastrointestinal or biliary disorders that could impair absorption, metabolism or excretion of orally administered medications, based on laboratory assessment at the time of screening visit. 7. hospitalization for acute decompensated heart failure within the 12 months preceding study enrollment. 8. a diagnosis of active protein losing enteropathy or plastic bronchitis. 9. active evaluation or listing for heart transplant. 10. history of use of a phosphodiesterase type 5 inhibitor within three months of study enrollment. 11. concurrent illness that, in the opinion of the investigator, precludes participation. 12. current therapy with alpha-blockers or nitrates. 13. pregnancy at the time of enrollment. 14. latex allergy

Keywords: fontan pharmacokinetics pharmacodynamics exercise capacity maximal oxygen consumption vascular function endopat myocardial performance
retrospective, non-significant risk, deep brain stimulation (dbs) care management software feasibility study

Conditions: Parkinson's Disease

Summary: to evaluate dbs device settings and match with the features of the dbs care management software.

this is a study done on parkinson disease subjects who have received the dbs system implanted in their subthalamic nucleus.

Eligibility criteria:
inclusion criteria: * patient with medtronic deep brain stimulation therapy for idiopathic levodopa responsive parkinson's disease * patient who has had lead placement in the subthalamic nucleus * patient with pre-op mri available * patient with post-op ct scan available showing placement of the lead * patient who has documented improvement of at least 35% on updrs iii scores from baseline preoperative off medication state compared to post dbs implant stimulation on/medications off exclusion criteria: * patient who has had clinically significant persistent stimulation related adverse effects * patient who has evidence of lead migration without lead revision * patient with other brain malformations that would make it difficult to process images (ablative surgery in the basal ganglia, resective surgery, brain tumor)
clinical study of pediatric acute liver failure

Conditions: Acute Liver Failure

Summary: the goal of this observational study is to understand the etiology, prognosis and influencing factors of acute liver failure in children, evaluate the predictive value of children's sofa score, peld score and liu score for the short-term mortality rate of children's liver failure and the infection of children's acute liver failure; analyze the bleeding and kidney damage of children's acute liver failure, and evaluate the quality of life of children's acute liver failure.

palf is a seriously life-threatening acute disease with a rapid onset, rapid progression and high mortality rate. especially under the influence of multiple organ dysfunction syndrome (mods) or other serious complications, clinical prognosis evaluation and treatment decision-making face great challenges.it aims to accurately evaluate the survival probability or liver transplantation needs of patients based on clinical data and biological indicators, and deeply reveal the impact of different factors on the prognosis of palf from the perspective of etiology, treatment mode (such as mechanical ventilation and plasma replacement) and complications (such as mods and its score), so as to provide a scientific basis for identifying high-risk groups, optimizing personalized treatment strategies and early diagnosis.

Eligibility criteria:
inclusion criteria: * （1) the age is less than 18 years old; (2) acute onset (≤8 weeks), no liver disease basis in the past; (3) biochemical evidence of severe liver injury ; (4) coagulation dysfunction that cannot be corrected by vitamin k: prothrombin time (pt) ≥15s or international standardized ratio (inr) ≥1.5, and accompanied by hepatic encephalopathy at the same time; or meet any of pt≥20s, inr≥2.0, may not be accompanied by hepatic encephalopathy; (5) provide complete clinical data and treatment records. (6) agree to participate in this study and obtain informed consent. exclusion criteria:(1) multiple organ failure caused by non-hepatic diseases; (2) missing data or incomplete follow-up information. -
relation between cachexia, diabetes and perineural invasion in pancreatic cancer- biomarkers substudy

Conditions: Pancreatic Cancer, Adult; Cachexia; Pain; Diabetes Mellitus

Summary: the purpose of this study is to determine the interrelationship between cachexia, neural invasion and diabetes in patients with pancreatic cancer. thus the investigators propose to identify the protein expression levels of activin and midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage.

in this study, the investigators will prospectively evaluate pancreatic adenocarcinoma patients with or without cachexia, perineural invasion and diabetes. patients with pancreatic ductal adenocarcinoma, based on the results of an endoscopic ultrasonography (eus) biopsy or surgery were enrolled at the diagnosis and blood samples are drawn. thus the investigators propose to identify the protein expression levels of activin and midkine in plasma of patients with different stages of pancreatic adenocarcinoma compared with benign pancreatic disorders and healthy patients and to evaluate the possible correlation with diabetes, tumor size and tumor stage. furthermore, the investigators propose to identify the prognostic role of these biomarkers in the development of metastasis and survival in patients with adenocarcinoma, with and without diabetes and cachexia; to identify a new biomarker predictive of cachexia and eventually to select patients likely to benefit from treatment with antagonists of activin (or hypoglycemic treatment) and investigating the role of invasion neural in the appearance of cachexia in patients with pancreatic adenocarcinoma. follow-up: with phone-calls on an every 6 month, for up to 2 years, retaining the following data: survival, date of decease and its direct cause, the presence of tumor recurrence.

Eligibility criteria:
inclusion criteria: 1. age over 18 years old 2. eus or surgery biopsy confirming the diagnosis of adenocarcinoma 3. informed consent exclusion criteria: 1. obvious malabsorption 2. artificial nutrition 3. hyperthyroidism 4. major depression 5. other causes of malnutrition 6. refusing to enter the study

Keywords: pancreatic cancer cachexia perineural invasion pain diabetes
comparative effectiveness study of transthoracic and transesophageal echocardiography in stroke

Conditions: Stroke, Acute

Summary: the comparative effectiveness study of transthoracic and transesophageal echocardiography in stroke (contest) aims at assessing the diagnostic value of transesophageal echocardiography (tee) and transthoracic echocardiography (tte) with regards to treatment consequences in patients with acute ischemic stroke.

for this purpose, the investigators will perform a prospective multicenter diagnostic comparative effectiveness study. patients with acute stroke will be studied by both tte and tee. patients with already defined stroke etiology and determined secondary prevention will be excluded from the trial. treatment relevant diagnostic findings will be identified by a central endpoint adjudication committee. in order to demonstrate a hypothesized 2% absolute increase in the number of treatment relevant diagnostic findings by tee as compared to tte, 880 stroke patients will be enrolled in six german stroke centers. contest will allow answering the question whether and for which group of stroke patients tee is indicated in addition to tte. by this, the study will provide evidence to guide justified recommendations for echocardiography in acute stroke patients.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke or transitory ischemic attack (tia) * age ≥18 years * informed consent exclusion criteria: * patients with already defined stroke etiology and determined secondary prevention treatment strategy prior to echocardiography (e.g. atrial fibrillation, carotid artery stenosis, cervical artery dissection)

Keywords: stroke, echocardiography
study of biotene oralbalance gel for oral care in critically-ill mechanically ventilated neonates

Conditions: Ventilator-associated Pneumonia

Summary: the goal of this pilot study is to test the hypothesis that mechanically ventilated infants receiving biotene oralbalance® gel for oral care would have a reduced intubation time compared to infants receiving oral care placebo. this study is also performed to test the feasibility as well the safety of biotene oralbalance® gel.

prolonged mechanical ventilation is a known risk factor strongly associated with ventilator-associated pneumonia (vap). as the fatality rates for vap are high, prevention of vap has focused on the use of "vap bundles". oral decontamination, by reducing the microbial burden within a patient's oral cavity, is an essential part of vap bundle strategy for reducing vap rates in mechanically ventilated adults and older children. however there are no published studies of oral care products for vap prevention in mechanically ventilated neonates. biotene oralbalance® gel contains antibacterial active ingredients, including lactoperoxidase, lysozyme and lactoferrin,all enzymes with bacteriostatic or bactericidal activity on selective oral microflora. we hypothesize that by directly reducing the oral microbial burden, we indirectly reduce the number of vap. this will be reflected in the reduced time on mechanical ventilation in the group of infants receiving biotene oralbalance® gel. this is a prospective, randomized, unmasked, controlled trial with 40 mechanically ventilated infants recruited from level iv nursery at forsyth medical center, winston-salem, nc. the participants will be randomized to two equal groups, stratified by gestational age categories: \ =28 weeks as well as multiple births. twenty infants will receive biotene oralbalance® gel (intervention group) and 20 infants will receive swabs with sterile water (control group) for timed oral care. both study groups will receive the nicu standard ventilator-associated pneumonia (vap) bundle, a combination of strategies aimed to reduce the rate of vap.

Eligibility criteria:
inclusion criteria: * neonates who are mechanically ventilated between 7 and 10 days old. signed parental informed consent is required for recruitment into the study. exclusion criteria: * neonates with chromosomal anomalies or major congenital anomalies, neonates with terminal conditions, neonates for whom a decision has been made not to provide full medical support, neonates whose parents refused or are unable to provide consent, and/or attending physician refusal.

Keywords: neonates mechanical ventilation oral care duration of mechanical ventilation feasibility ventilator-associated pneumonia
expanded access with trappsol(r) cyclo (tm) for an individual patient with late onset alzheimer's disease

Conditions: Late Onset Alzheimer Disease

Summary: to afford urgent access to a potential-disease modifying treatment, dr. diana kerwin, in partnership with ctd holdings, the manufacturer of trappsol (r) cyclo(tm), will administer the product to a patient with alzheimer's disease who has no other disease-modifying treatment options.

trappsol(r) cyclo(tm) will be administered via intravenous (iv) infusion. the initial dose will be 500 mg/kg (t=day 0). subsequent dosing is anticipated to increase over 9 months, with all subsequent doses given monthly at the maximum dose determined by tolerability, lack of toxicity or adverse event, pharmacokinetic analysis and patient preference. so long as the overall risk/benefit profile favors continued dosing, the patient will continue to receive trappsol (r) cyclo (tm) for a minimum of 12 months, if not perpetually. risk/benefit assessments will include: * vital signs, ecg and laboratory parameters (cbc, chemistry panel, hematology, urinalysis, lipids, coagulation) * brain mri without gadolinium for safety monitoring * amyloid and tau pet (positron emission tomorgraphy) imaging * adverse events * mini-mental status score * digital cognition technologies (dct) clock * changes in blood biomarkers * pharmacokinetic data

Eligibility criteria:
inclusion criteria: patient with alzheimer's disease who continued to decline neurologically and had no other treatment options with intent to halt progression available. all other medical conditions stable \& well-managed. - exclusion criteria: -
influence of psychological status on the results of pain treatment in patients with gunshot and mine-explosive wounds

Conditions: Chronic Pain; Psychological Disorders

Summary: 82.1% of patients with gunshot and mine-explosive wounds and wounds during hostilities in ukraine have negative results of pain treatment, which leads to its chronicity. examining the effect of psychological status on pain management outcomes in these patients may improve their treatment outcomes.

the influence of the amount of damage and operative interventions on the results of pain treatment in patients with gunshot and mine-explosive wounds at the stages of treatment needs to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have its features. since in 82.1% of cases it is not possible to achieve a positive result of treatment, the data of our study will play an important role in their treatment.

Eligibility criteria:
inclusion criteria: * availability gunshot and mine-explosive wounds exclusion criteria: * absence gunshot and mine-explosive wounds

Keywords: chronic pain, gunshot wounds, mine-explosive wounds, psychological disorders